Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: cyclophosphamide; Drug: etoposide; Drug: BCNU

• Registration Number: NCT00005613
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.

Detailed Description

OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

Study Timeline

• Study Start: 1996-03
• Study First Submitted: 2000-05-02
• Study First Submitted QC: 2004-06-24
• Study First Posted: 2004-06-25
• Primary Completion: 2006-10
• Study Completion: 2010-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Transplant	cyclophosphamide	autologous hematopoietic progenitor cell transplant
Autologous Transplant	etoposide	autologous hematopoietic progenitor cell transplant
Autologous Transplant	BCNU	autologous hematopoietic progenitor cell transplant
Allogeneic Transplant	cyclophosphamide	allogeneic hematopoietic progenitor cell trasnplant
Allogeneic Transplant	BCNU	allogeneic hematopoietic progenitor cell trasnplant
Allogeneic Transplant	etoposide	allogeneic hematopoietic progenitor cell trasnplant

Primary Outcome Measures

Name	Time	Method
relapse rate	5 years	determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation

Trial Locations

Locations (2)

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States